CLEANING VALIDATION ENGINEER Details

splintpharma - Newark, DE

Employment Type : Full-Time

Responsibilities Include:

    Drafting of development and validation protocols related cleaning of manufacturing equipment.
    Working with Manufacturing to optimize and validate cleaning processes.
    Contributing to resolution of aberrant cleaning results.
    Compiling data and generating validation reports.


Job Requirements:

    Basic understanding of cleaning validation concepts including dirty and clean hold times,
    campaign lengths, and carryover acceptance criteria.
    Ability to train on and assist with equipment cleaning with Manufacturing support.
    Good technical writing skills. Some documents can be drafted remotely.
    Good communication skills. Ability to provide concise updates in writing and in person.
    Ability to work off-shifts to perform developmental and validation cleaning trials to maintain manufacturing schedules.

Education and Experience:

    Bachelor’s degree in science related field
    Minimum of 2 years’ experience in pharmaceutical / biopharmaceutical companies
    Some experience in cleaning validation preferred